RegDesk Blog

The Medical Device Rules, 2017 went into effect the beginning of this year, January 2018. Though the Act comprehensively covers “medical devices”, it failed to providing details for In Vitro Diagnostic devices (IVDs), digital health products, and software products. Recently, the Central Drugs Standards Control Organization (CDSCO) released a document...

COFEPRIS, Agency that regulates food, medical devices and drugs in Mexico, has issued 288,000 import and export permits for products in the last 5 years. COFEPRIS recently signed an agreement with the Confederation of Associations of Customs Agents of the Mexican Republic (CAAAREM) to promote foreign trade of health supplies....

The National Health Surveillance Agency of Brazil, ANVISA, has proposed a new guideline for importation of products subject to sanitary surveillance. This effort has been made to ease importation burden and increase speed to market. ANVISA issues three hundred thousand import licenses each year through its Integrated Foreign Trade System...

COFEPRIS, the decentralized division of the Department of Health in Mexico, is the governing body for medical devices and medicines. COFEPRIS has officially joined the Pharmaceutical Inspection Cooperation Scheme (PIC/S), which bridges the most important regulatory agencies in the world. COFEPRIS plans on promoting regulatory policy that guarantees access of...

ANVISA recently introduced a new requirement for medical device manufacturers who will be conducting clinical investigations. Sponsors will need to submit Medical Device Clinical Dossier clinical (DICD). This resolution will be applicable to all clinical trials with medical devices for registration in Brazil. DICD is compilation of documents to be...

A harmonized standard is a European standard developed by the following recognized European Standards Organizations: CEN, CENELEC, or ETSI. Manufacturers and conformity assessment bodies use harmonized standards to demonstrate products or processes comply with the relevant EU legislation. The references for the harmonized standards are published in the Official Journal...

The Chinese Food and Drug Administration (CFDA) is the regulatory body in China that oversees the safety and efficiency of foods, pharmaceuticals, medical devices, and cosmetics. The CFDA recently issued regulations to enforce record-keeping of clinical trial institutions for medical devices. The new regulations will go into effect on January...

After much anticipation and uncertainty, the European Medicines Agency (EMA) has a new home, post-Brexit. It’s Amsterdam! The Council of European Union comprised of 27 EU member states arrived at the decision on Monday, November 20 after three rounds of voting and a drawing of lots. The result alleviates the...